Regulatory Labeling Strategist, Manager - Remote

Overview

The Regulatory Labeling Strategist, Manager at Amgen is responsible for driving labeling strategy and managing the end-to-end labeling processes for pre- and post-marketed products, ensuring compliance with regulatory requirements.

In Short

• Drive labeling strategy for products.
• Develop and maintain labeling documents.
• Manage the labeling process for product life cycles.
• Lead cross-functional labeling teams.
• Provide strategic guidance on labeling regulations.
• Consult on high-quality core labeling documents.
• Review deviations from labeling procedures.
• Support responses to Health Authority queries.
• Contribute to annual and safety reports.
• Foster continuous improvement in labeling processes.

Requirements

• Doctorate or Master’s degree with relevant experience.
• Knowledge of global labeling regulatory requirements.
• Strong analytical and problem-solving skills.
• Excellent collaboration and negotiation abilities.
• Strong attention to detail and organizational skills.
• Proficient in Microsoft Suite.
• Experience in pharmaceuticals or life sciences preferred.
• Project management experience is a plus.
• Strong verbal and written communication skills.
• Experience with Veeva-based systems is advantageous.

Benefits

• Comprehensive employee benefits package.
• Retirement and savings plan with company contributions.
• Flexible work models, including remote work.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Career development opportunities.
• Health and welfare plans for employees and dependents.
• Work/life balance support.
• Inclusive environment fostering diversity.